BROOK JACKSON CALLS FOR FDA TO PHYSICALLY INSPECT PFIZER'S SITE MANAGEMENT ORGANISATION
The evidence is stark - Did Ventavia break US law?
WHAT IS A SITE MANAGEMENT ORGANISATION (SMO)?
These are business organisations that provide clinical research services to pharmaceutical companies and contract research organisations (CROs) developing and commercializing new medicines. Brook Jackson was hired by Ventavia, a SMO working on Pfizer’s clinical trials programme, as part of its leadership team. Inside Pharma reported on this previously:
WHY CALL FOR FDA TO TURN UP AT VENTAVIA’S SITES FOR THOROUGH INSPECTIONS?
Data integrity issues have been top of FDAs list of non-compliances for many years now. This slide-deck gives background. It was presented by CAPT Sharon K. Pederson (Thoma), PharmD, National Expert of Pharmaceutical Inspections, Food and Drug Administration, at a parenteral drug association (PDA) meeting dated February 6 2017.
It begins “What is Data Integrity? Complete, consistent, and accurate data to assure patient safety and product quality.”
It continues on:
Complete, consistent, and accurate data should be attributabl…